Performance qualification certificate

The apparatus suitability test described in USP General Chapter <711> Dissolution is equivalent to a performance qualification.5 The determination of suitability of a test assembly to perform dissolution testing must include conformance to the dimensions and tolerances of the apparatus. In addition, the critical test parameters that have to be monitored periodically include volume and temperature of the dissolution medium, rotation speed (Apparatuses 1 and 2), dip rate (Apparatus 3), and flow rate of medium (Apparatus 4). This test requires that the USP Calibrator Tablets (now known as Performance Verification Standard Tablets) be tested the dissolution results must be within the ranges stated in the certificate of the calibrator tablets. The performance verification standard tablets include USP Chlorpheniramine Maleate Extended-Release Tablets RS, USP Prednisone Tablets RS, and USP Salicylic Acid Tablets RS. 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

Implement an effective process for monitoring and docrunenting all drivers job fiinctions, training, qualifications, renewal dates, disclosed medical conditions, and operational restrictions, including those of drivers on a waiver program or with impairments that may be satisfied by a Skill Performance Evaluation certificate, to ensure that assignments are covered by qualified drivers. 

In brief, the auditor has to be qualified by lATF to perform the audits and, to be eligible for qualification, the auditor has to be sponsored by an lATF-approved certification body that is subject to witness audits performed by qualified auditors from vehicle manufacturers. Such measures will inevitably improve the quality of certification offered by certification bodies and will be good for the global automotive industry. 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

This requirement poses something of a dilemma when purchasing subcontract labor because it cannot be treated the same as product. You still need to ensure, however, that the labor conforms with your requirements before use. Such checks will include verification that the personnel provided have the requisite qualifications, skills, and knowledge and they are who they say they are. These checks can be made on the documentary evidence provided, such as certificates, but you will probably wish to monitor their performance because it is the effort you have purchased, not the people. You will not be able to verify whether they are entirely suitable until you have evaluated their performance. Subcontract labor could be classified as product released prior to verification being performed and so you need to keep records of the personnel and their performance during the tenure of the contract. 

A qualification verification certificate should be referenced, verifying that all individuals performing the OQ protocol are qualified to perform this protocol. This may be included as part of an overall IQ/OQ protocol. 

Personnel performing examinations other than visual shall be qualified in accordance with apphcable portions of SNT TC-IA, Recommended Practice for Nondestructive Testing Personnel Qualification and Certification. Procedures shall be qualified as required in Par. T-150, Art. 1, Sec. V of the ASME Code. Limitations on imperfections shall be in accordance with the engineering design but shall at least meet the requirements of the code (see TaBles 10-54 and 10-55) for the specific type of examination. Repairs shall be made as applicable. 

The certification activities include a series of process documentation and qualification studies that start with the initial installation of a sterilization system and continue as process engineering changes or new or revised product introductions are required. Qualification activities comprise installation, operational, change, and performance phases. 

In the second edition, 64 new validation SOPs are added to describe documentation required for sterility assurance, qualification and requalification template reports of major sterile equipments, critical applicable procedures, templates for certification guidelines, media fill procedures, environmental control guidelines, training, and critical environmental performance evaluation procedures. 

Having chosen the analytical instrument or system, Installation Qualification, IQ, should be carried out to ensure that the equipment works the way the vendor or manufacturer specifies it should. IQ should be performed in accordance with a written test protocol with acceptance criteria with certification from the installation engineer, who is suitably qualified. Full written records of all testing carried out should be maintained as well as ensuring that adequate documentation and manuals have been supplied. The latter should include any Health Safety information from vendor or manufacturer. 

Certification of revalidation can be useful however, the manner in which formal approvals are documented is best left up to each individual firm, and use of formalized certifications should be considered entirely optional. Certification is documented testimony by qualified authorities that a system s qualification, calibration, validation, or revalidation has been performed properly and the results are acceptable. 

The tests will be broken into Hardware Acceptance Tests (or Installation Qualification), System Acceptance Tests (or Operational Qualihcation), and Equipment Tests (or Performance Qualihca-tion). According to the size of the unit, all tests may be in one test document or there may be three separate Qualification documents. A test document will define the test philosophy and how the tests should be run. Each test will have a tide, a reason for the test, an oudine of any test equipment required, a description of the test, data to be recorded, and the test acceptance criteria. Calibrated test equipment must be supported with cahbration certificates. 

It is worth stressing that future changes to the process (e.g. a new component supplier or component design) could degrade the operational performance and take it out of certification . Any change must therefore lead to a review, an outcome of which could be re-validation/re-qualification. 

Qualifications Were all maintenance personnel qualified in terms of education, training, and/or experience to perform aligned tasks If special licenses or certifications were required, did personnel have them ... 

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